Evaluate the Safety And Efficacy of the Transradial Coronary in Comparison With the Transfemoral Coronary Intervention

NCT01704911 | Unknown DMC

• 1 other identifier: DRAGON
• Study Type: interventional
• Target: 1,700
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of the DRAGON clinical trial is to evaluate the safety and efficacy of the transradial coronary intervention (TRI) in comparison with the transfemoral coronary intervention (TFI).

Conditions

Free Rate of Cardiac or Cerebrovascular Events; Transradial-transfemoral Coronary Interventions Comparison

Keywords

Transradial; Transfemoral; Coronary Intervention

Outcome Measures

Primary Outcomes (1)

• major adverse cardiac or cerebrovascular events free rate

  one year

Secondary Outcomes (1)

• the major bleeding complication (BARC definition type 3 or 5)-free rate

  7 days

Study Arms (2)

Transradial Coronary Intervention

EXPERIMENTAL

Transradial Coronary Intervention

Procedure: Transradial Coronary Intervention; Device: Coronary Stent System

Transfemoral Coronary Intervention

EXPERIMENTAL

Transfemoral Coronary Intervention

Procedure: Transfemoral Coronary Intervention; Device: Coronary Stent System

Interventions

Transradial Coronary Intervention PROCEDURE

Transradial Coronary Intervention

Transfemoral Coronary Intervention PROCEDURE

Transfemoral Coronary Intervention

Coronary Stent System DEVICE

Any kind of coronary stent system

Transfemoral Coronary Intervention; Transradial Coronary Intervention

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patient must be at least 18 years of age.
• Patient is able to verbally acknowledge an understanding of the associated risks, benefits and treatment alternatives and he or his legally authorized representative provides signed informed consent prior to the randomization, as approved by the appropriate IEC.
• Patient must have evidence of myocardial ischemia (e.g., stable or unstable angina, silent ischemia, positive functional study or a reversible changes in the electrocardiogram (ECG) consistent with ischemia).
• Patient must be an acceptable candidate for coronary artery bypass graft (CABG) surgery.
• Allen test is required for suitable candidate.
• Patient must agree to undergo all protocol-required follow-up examinations.
• Patient must agree not to participate in any other clinical study within the duration of this trial.
• Target lesion must be able to be treated by using six-French guiding catheters.
• Target lesion can be de Novo or restenotic.
• The target lesion can be stable or unstable.

You may not qualify if:

• Patient has received a heart transplant or any other organ transplant or is on a waiting list for any organ transplant.
• Patient is receiving or scheduled to receive chemotherapy for malignancy within 30 days prior to or after the procedure.
• Patient is receiving immunosuppression therapy or has known immunosuppressive or autoimmune disease (e.g. Human Immunodeficiency Virus, Lupus etc.).
• Patient has extensive peripheral vascular disease that precludes safe 6 French sheath insertion.
• Patient has other medical illness (e.g., cancer or congestive heart failure) that may cause non-compliance with the protocol, confound the data interpretation or is associated with a limited life expectancy (i.e., less than one year).
• Female patients of childbearing potential who have refused a urine or blood pregnancy test (to be done within 7 days prior to index procedure), patients who are nursing at the time of index procedure and those patients who do not agree at the time of consent to use any approved form of birth control up to and including the follow-up at 1 year.
• The target lesion is considered not to be treated by using six-French guiding catheters.

Sponsors & Collaborators

• CCRF Consulting Co., Ltd.: lead
• Peking University First Hospital: collaborator
• Terumo Medical (Shanghai) Co.,Ltd.: collaborator

Study Sites (1)

Peking University First Hospital

Beijing, 100034, China

Location

Study Officials

• Shigeru Saito, MD

  Shonan Kamakura General Hospital, Japan

  PRINCIPAL INVESTIGATOR

• Yong Huo, MD

  Peking University First Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Yong HUO, MD

CONTACT

861084059198; ybwang@ccrfmed.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 9, 2012
• First Posted: October 12, 2012
• Study Start: October 1, 2012
• Primary Completion: December 1, 2014
• Study Completion: March 1, 2015
• Last Updated: October 26, 2012

Record last verified: 2012-10

Locations

CN (1)